PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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Model Number 20 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/18/2014 |
Event Type
malfunction
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Event Description
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The customer, a biomedical engineer, contacted physio-control to report that their device had failed a preventative maintenance test.During testing the device gave an "abnormal energy delivered" message and the unit had a service indicator present.Further inspection showed the device had logged event code 9c19 in the memory.The event code is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control examined the customer's device and verified the reported issue, also noting that there was a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.Physio then replaced the therapy pcb assembly, as well as other unrelated repairs, and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was a diode, designator cr30.The diode was shorted from pins 5 to 9.
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